BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEX GENERATOR

    MDR report key: 5731877 · Received June 17, 2016

    Report

    Report Number
    1226420-2016-00081
    Event Type
    Malfunction
    Date Received
    June 17, 2016
    Date of Event
    May 12, 2016
    Report Date
    August 16, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY
    Product Code
    GEI
    PMA / PMN Number
    K143175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): BRIEF DESCRIPTION OF COMPLAINT: THE SURGEON REPORTED A SPARK FROM THE DEVICE, CAUSING THE ICD LEAD TO STAIN. INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) SLHR REVIEW COMPLAINT DEVICE DETAILS: PRODUCT CODE (CFN): 40-405-1 SERIAL: (B)(4) TESTING PERFORMED: VISUAL INSPECTION: PACKAGING: GENERATOR WAS RETURNED IN AN APPROVED MAE BOX WITH PROPER FOAM PROTECTION. THE PACKAGING DID NOT APPEAR TO HAVE SUSTAINED DAMAGE DURING TRANSIT. EXTERNAL VISUAL: THERE WAS NO EVIDENCE OF EXTERNAL DEFECTS TO THE GENERATOR. INTERNAL VISUAL: THERE WAS NO EVIDENCE OF INTERNAL DEFECTS TO THE GENERATOR. UNIT WAS NOT OPENED. FUNCTIONAL INSPECTION: TEST(S) PERFORMED IN ACCORDANCE WITH REPORTED ISSUE: FUNCTIONAL TEST, MONOPOLAR POWER OUTPUT TEST (TABLE 1) MEASUREMENTS ARE WITHIN SPECIFICATION. EQUIPMENT USED FOR TESTING: PS210-030S, PS200-040, 23-112-1, 7254, 7255, 7282 RESULTS OF EACH TEST PERFORMED: THE GENERATOR SUCCESSFULLY PASSED ALL REQUIREMENTS FOR BOTH FUNCTIONAL TEST AND MONOPOLAR POWER OUTPUT TEST. NO SPARK WAS OBSERVED DURING TESTING. THE FOLLOWING IMPACTS TO FUNCTIONALITY WERE IDENTIFIED: N/A DEFECTS WERE RESOLVED BY: N/A THERE WERE NO ADDITIONAL FAILURES FOUND DURING ANALYSIS. SLHR REVIEW: THIS GENERATOR HAS NO HISTORY OF SERVICE RELATED TO THE CURRENT FINDINGS. INVESTIGATION CONCLUSION: THE REPORTED ISSUE WAS NOT CONFIRMED. REFERENCE DOCUMENTS: COMPLAINT ANALYSIS-GENERATORS-WORK INSTRUCTIONS, 42-10-1119 REV. B AEX SERVICE PROCESS INSTRUCTIONS , 61-90-0703 REV. E.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBATIN THE INFORMAITON FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING AN ICD EXCHANGE THE SURGEON ACTIVATED THE PLASMABLADE DEVICE AND REPORTED A SPARK ON THE TISSUE CAUSING A STAIN ON ONE OF THE ICD LEADS. THE SURGEON WIPED OFF THE STAIN AND REPORTED NO TISSUE DAMAGE OR IMPACT TO THE LEAD.

    Description of Event or Problem · 1

    DURING AN ICD EXCHANGE THE SURGEON ACTIVATED THE PLASMABLADE DEVICE AND REPORTED A SPARK ON THE TISSUE CAUSING A STAIN ON ONE OF THE ICD LEADS. THE SURGEON WIPED OFF THE STAIN AND REPORTED NO TISSUE DAMAGE OR IMPACT TO THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386710 AEX GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY 40-405-1

    Patients

    Seq Age Sex Outcome Treatment
    1